Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study

Not Applicable

Completed

• Conditions: Lung-protective Ventilation; Respiratory Function Monitor
• Interventions: Device: Ventilations while using a respiratory function monitor

• Registration Number: NCT05512689
• Lead Sponsor: Medical University of Vienna

Brief Summary

This study was a non-blinded, non-randomized intervention study in a single-center clinical setting, analyzing ventilation quality with and without RFM visibility.

Detailed Description

The study was conducted at the Neonatal Intensive Care Unit and the delivery room at the Division of Neonatology, at the Medical University of Vienna.

We aimed to record ventilation parameters (tidal volume, mask leak, ventilation rate, PIP, PEEP) using a CE-certified Respiratory Function Monitor (Neo100, Monivent AB, Gothenburg, Sweden), which was either hidden or visible to the provider responsible for the airway (airway provider), during ventilations on term and preterm patients at the NICU and the delivery room.

The investigators aimed to determine the quality of ventilations performed by healthcare professionals depending on RFM visibility. Analysis occurred, determining whether observing the data displayed on the RFM during PPV of preterm and newborn infants lead to adjustments in applied pressure and an increase in the proportion of inflations performed within a predefined range of 4-8 ml/kg for VTe.

The investigators hypothesized that using a RFM with numeric and graphical display of values during positive pressure ventilation of infants will lead to i) more frequent recognition and correction of tidal volumes outside the predefined range and ii) reduction of mask leak.

This knowledge gain may improve future training using a RFM to improve the quality of ventilations and, thereby, patient safety.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-20
• Study First Posted: 2022-08-23
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients at the Neonatal Intensive Care Unit (NICU) and in the delivery room who receive positive pressure ventilation
• Written consent from parents or legal guardians of patients
• Preterm and term infants (male and female, any gestational age)

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Exclusion Criteria

• Healthcare professionals or parents/legal guardians, representing their children, that do not consent to participation in this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Interventional group	Ventilations while using a respiratory function monitor	In the interventional group, healthcare professionals will ventilate the infants using the RFM and are able to adapt their ventilations according to the RFM feedback.

Primary Outcome Measures

Name	Time	Method
Proportion of ventilations with VTe between 4-8ml/kg	through study completion, an average of 1 year	percentage of ventilations within range divided through all ventilations performed, for each participant

Secondary Outcome Measures

Name	Time	Method
Mean value for peak inflation pressure	through study completion, an average of 1 year	defined as \> 35 cmH2O
Occurrence of insufficient tidal volume (defined as <4mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)	through study completion, an average of 1 year	defined as \< 4ml/kg
Occurrence of excessive tidal volume (defined as >8mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)	through study completion, an average of 1 year	defined as \> 8ml/kg
Comparison of elective versus delivery room interventions	through study completion, an average of 1 year	mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison
Mean value for ventilation rate (defined as ventilations per minute)	through study completion, an average of 1 year	defined as ventilations per minute
Mean value for mask leak and proportion of ventilations with excessive mask leak (defined as >50%) during all ventilations	through study completion, an average of 1 year	defined as \> 50%
Comparison of ventilations via face mask vs. endotracheal tube	through study completion, an average of 1 year	mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison
Outcome data and adverse events	through study completion, an average of 1 year	this included diagnoses (i.e., bronchopulmonary dysplasia \[BPD\], persistent ductus arteriosus \[PDA\], IVH, periventricular leukomalacia \[PVL\], and pneumothorax) and the time frame of occurrence (within 24 hours, one week, or during the total hospital stay). BPD was defined as the need of any respiratory support at the GA of 36 weeks, evaluated for infants below 32+0 weeks GA. IVH was determined using the DEGUM classification
Comparison of fellows vs. consultants	through study completion, an average of 1 year	mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison
Comparison of sef-inflating-bag vs. neo-T	through study completion, an average of 1 year	mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria